Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns

Crucell

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: Engerix B; Biological: HepavaxGene (thiomersal free)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01349283

HVG-V-A002

Details and patient eligibility

About

The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion of the immunization schedule.

Enrollment: 1,738 patients

Sex: All

Ages: Under 1 day old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Three types of subject:

Neonates whose mothers are positive for both HBsAg and HBeAg

Neonates whose mothers are positive for only HBsAg

Neonates whose mothers are negative for both HBsAg and HBeAg

INCLUSION CRITERIA:

• Full-term neonates with gestational age from 37 weeks to 42 weeks;
• Apgar scores are no less than 7 at birth;
• Neonates with standard body temperature (auxiliary temperature < 37.1°);
• Neonates weighing ≥ 2,500 grams at birth;
• Neonates with icteric index within the normal range (physiologic jaundice is permitted);
• Informed consent form signed by parent/guardian;
• The requirements of the clinical trial protocol can be observed on the basis of the opinion of the investigator.

EXCLUSION CRITERIA:

• Subject's parent has a history of family diseases such as convulsion and brain diseases;
• Mothers have low immunologic function or a history of organ transplantation or hemodialysis;
• Subject's parent is allergic to any composition of Hepatitis B vaccine;
• A family history of thrombocytopenia, or other disturbance of blood coagulation, which may result in a contraindication for intramuscular injection;
• Known immunologic function damage;
• Mothers had received gamma globulin or immunoglobulin injection during pregnancy;
• Any congenital malformation
• Known or suspected to suffer from diseases such as active infection and cardiovascular disease;
• Any condition believed by the investigator to have possible impact on trial evaluation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,738 participants in 6 patient groups

HepavaxGene Stratum 1a

Experimental group

Description:

Subjects of mothers with chronic hepatitis B (positive for both HBsAg and hepatitis B envelope antigen - HBeAg)

Treatment:

Biological: HepavaxGene (thiomersal free)

Comparator vaccine Stratum 1a

Active Comparator group

Description:

Subjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg)

Treatment:

Biological: Engerix B

HepavaxGene Stratum 1b

Experimental group

Description:

Subjects of mothers with chronic hepatitis B (positive for HBsAg only)

Treatment:

Biological: HepavaxGene (thiomersal free)

Comparator vaccine Stratum 1b

Active Comparator group

Description:

Subjects of mothers with chronic hepatitis B (positive for HBsAg only)

Treatment:

Biological: Engerix B

HepavaxGene Stratum 2

Experimental group

Description:

Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)

Treatment:

Biological: HepavaxGene (thiomersal free)

Comparator vaccine Stratum 2

Active Comparator group

Description:

Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)

Treatment:

Biological: Engerix B